Replacement valve and method

ABSTRACT

A replacement valve has an expandable frame configured to engage a native valve and a valve body mounted to the expandable frame. The valve body can have a plurality of valve leaflets configured to open to allow flow in a first direction and engage one another so as to close and prevent flow in a second direction, the second direction being opposite the first direction.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No.61/445,963, filed Feb. 23, 2011. This application is also related toU.S. application Ser. No. 12/569,856, filed Sep. 29, 2009, Ser. No.12/761,349, filed Apr. 15, 2010, Ser. No. 13/165,721, filed Jun. 21,2011, and Ser. No. 13/244,080, filed Sep. 23, 2011. These relatedapplications provide context for the present disclosure, and in someinstances the present disclosure describes embodiments and principlesthat build on the previous applications. All of the above applicationsare hereby incorporated herein by reference in their entirety and are tobe considered a part of this specification.

BACKGROUND

Field of the Invention

Certain embodiments disclosed herein relate generally to replacementvalves for a vascular system. In particular, the valves relate toreplacement heart valves, such as for the mitral valve.

Description of the Related Art

Human heart valves, which include the aortic, pulmonary, mitral andtricuspid valves, function essentially as one-way valves operating insynchronization with the pumping heart. The valves allow blood to flowdownstream, but block blood from flowing upstream. Diseased heart valvesexhibit impairments such as narrowing of the valve or regurgitation,which inhibit the valves' ability to control blood flow. Suchimpairments reduce the heart's blood-pumping efficiency and can be adebilitating and life threatening condition. For example, valveinsufficiency can lead to conditions such as heart hypertrophy anddilation of the ventricle. Thus, extensive efforts have been made todevelop methods and apparatus to repair or replace impaired heartvalves.

Prostheses exist to correct problems associated with impaired heartvalves. For example, mechanical and tissue-based heart valve prosthesescan be used to replace impaired native heart valves. More recently,substantial effort has been dedicated to developing replacement heartvalves, particularly tissue-based replacement heart valves that can bedelivered with less trauma to the patient than through open heartsurgery. Replacement valves are being designed to be delivered throughminimally invasive procedures and even percutaneous procedures. Suchreplacement valves often include a tissue-based valve body that isconnected to an expandable frame that is then delivered to the nativevalve's annulus.

Development of replacement heart valves that can be compacted fordelivery and then controllably expanded for controlled placement, andthe related delivery devices have proven to be particularly challenging.

SUMMARY

Accordingly, there is in the need of the art for improved replacementheart valves, among other things.

In some embodiments a replacement heart valve can comprise an expandableframe, and a valve body. The expandable frame can be configured toengage a native valve annulus, wherein the frame extends longitudinallybetween an upstream end and a downstream end, the frame having aforeshortening portion at or adjacent the downstream end, theforeshortening portion comprising foreshortening cells that arelongitudinally expanded when the frame is in a radially compacted stateand longitudinally contracted when the frame is in a radially expandedstate. The valve body can be coupled to the frame, the valve bodycoupled to the frame in the foreshortening portion in a manner so thatthe frame foreshortening portion can move longitudinally relative to thevalve body. Upon radial compaction of the implant, the frameforeshortening portion can longitudinally expand but moves relative tothe valve body so that the valve body substantially retains itslongitudinal length.

According to some embodiments, a method of implanting a replacementheart valve can comprise one or more of the following steps. Advancing areplacement heart valve to a native valve annulus. Expanding a frame ofthe replacement heart valve from a compacted position to a firstexpanded configuration such that anchors on the replacement heart valveengage the native valve annulus. Reducing the diameter of the frame fromthe first expanded configuration to a second expanded configurationwhile the anchors remain engaged with the native valve annulus.

Reducing the diameter may further comprise deploying an outer ringpositioned around the frame, the outer ring having a relaxed diameterless than a diameter of the frame when in the first expandedconfiguration. Reducing the diameter may further comprise tensioning acord member disposed about the frame.

In some embodiments, a replacement heart valve can include aself-expandable frame, a valve body mounted to the self-expandableframe, and a tether or ring. The self-expandable frame can be configuredto engage a native valve annulus when in an expanded configuration. Theself-expandable frame can have a first diameter when in a relaxed, fullyexpanded configuration. The valve body can include a plurality of valveleaflets configured to open to allow flow in a first direction andengage one another so as to close and prevent flow in a seconddirection, the second direction being opposite the first direction. Thetether or ring can have a second diameter when in a relaxed, fullyexpanded configuration, the tether or ring being fit about a portion ofthe self-expandable frame, where the first diameter is greater than thesecond diameter.

In some embodiments, a replacement heart valve can comprise anexpandable frame configured to engage a native valve annulus, and avalve body mounted onto the expandable frame. The valve body can includea valve skirt configured to engage the expandable frame through a seriesof stitches, and a plurality of valve leaflets attached to the valveskirt. An upstream edge of each valve leaflet can be arcuate and aportion of the skirt can have an arcuate upstream edge substantiallyaligned with the valve leaflet upstream edges, wherein the aligned skirtand valve leaflet upstream edges can be attached to one another.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects and advantages are described belowwith reference to the drawings, which are intended to illustrate but notto limit the invention. In the drawings, like reference charactersdenote corresponding features consistently throughout similarembodiments.

FIG. 1 illustrates a side view of a replacement heart valve implant inan expanded state in accordance with one embodiment.

FIG. 2A is a schematic side view of another replacement heart valveimplant in a first expanded state.

FIG. 2B is a schematic side view of the replacement heart valve of FIG.2A in a second expanded state.

FIG. 3A is a schematic side view of another replacement heart valveimplant in a first expanded state.

FIG. 3B is a schematic side view of the replacement heart valve of FIG.3A in a second expanded state.

FIG. 4A is a schematic side view of the anchors of the replacement heartvalve implant of FIG. 1.

FIGS. 4B-E are schematic side views of reverse foreshortening anchors ofanother embodiment of replacement heart valve.

FIG. 5 is a side view of another embodiment of a replacement heart valvein an expanded state.

FIG. 6A is a side view of portions of an embodiment of valve leaflets ofa replacement heart valve.

FIGS. 6B-6C are portions of embodiments of valve skirts for replacementheart valves.

FIGS. 7A-7B are side views of a portion of the replacement heart valveof FIG. 1 in various stages of assembly in the expanded state.

FIG. 8 is a schematic view of another embodiment of a replacement heartvalve.

FIGS. 9A-9B are schematic views of another embodiment of a replacementheart valve.

DETAILED DESCRIPTION

The associated drawings and specification discuss aspects and featuresof the present invention in the context of several different embodimentsof heart valve implants, delivery devices and methods that areconfigured for use in the vasculature of a patient. Discussing thesefeatures in connection with heart valve implants employing stentsprovides for clarity and consistency in presenting these inventivefeatures and concepts. However, it is to be understood that the featuresand concepts discussed herein can be applied to products other thanheart valve implants.

FIG. 1 illustrates one embodiment of a replacement heart valve 10. Theillustrated replacement heart valve 10 is designed to replace a diseasednative mitral valve. One of any number of different heart valve designscould be used. In this embodiment, the replacement heart valve 10 ismade up of an expandable frame 20 to which a valve body 31 is attached.The expandable frame 20 can be configured to engage a native valveannulus with anchors 34, 36. The valve body 31 can include flexibleleaflets that open and close, as discussed in the related applicationspreviously incorporated by reference. Thus, the implanted replacementheart valve 10 can be secured to the native valve annulus with the frame20 and the valve body 31 can regulate the flow of blood through thevalve.

As shown in FIG. 1, the valve 10 has an upstream or inflow end 22 and adownstream or outflow end 26. The frame 20 has a first diameter at theupstream end 22 that is substantially less than a second diameter at thedownstream end 26. A transition portion 24 is positioned between the twoends of the frame 20.

The frame 20 can be constructed with a foreshortening portion 28 so thatpart of the frame foreshortens as the frame is radially expanded from acollapsed or compacted configuration. In the illustrated embodiment, theforeshortening portion 28 generally corresponds with the downstream end26. A non-foreshortening portion 30 can extend upstream from theforeshortening portion 28, and can generally correspond with theupstream 22 and transition 24 portions. The foreshortening portion 28can include a plurality of undulating struts that form a portion of thegenerally oval, diamond, or other shaped cells 32 that can extendcircumferentially around the frame to form the ring, or rings, of theforeshortening portion. The cells' longitudinal length increases whenthe frame radially compacts and the length shortens when the frameradially expands, providing the foreshortening feature of the valveframe. The foreshortening portion 28 can include foreshortening cells 32that are longitudinally expanded when the frame 20 is in a radiallycompacted state and longitudinally contracted when the frame is in aradially expanded state.

The anchors 34, 36 can be positioned to be on either side of theforeshortening portion 28. This can allow the anchors to move relativeto one another. In this way, with the anchors 34, 36 positioned oneither side of the valve annulus of the diseased heart valve, expansionof the frame causes the opposing anchors 34, 36 to move toward oneanother, and can allow the replacement heart valve to be secured to thevalve annulus through the anchors grasping opposite sides of theannulus. The valve implant 10 is shown with the downstream end 26, orthe downstream-most portion of the anchor 34, coupled to a loadingdevice configured to form and load the valve implant 10 onto a deliverydevice.

In some instances, there is a potential for a patient, having received areplacement heart valve, to develop an enlarged valve annulus. This maybe due to radially outward force exerted on the annulus byself-expanding of the replacement heart valve over an extended period oftime, among other features. An enlarged mitral valve annulus can impairvalve function and result in left atrial and ventricular enlargement andsignificant mitral regurgitation. Accordingly, there is a need in theart for apparatus and methods to mitigate the risk of valve frameinduced enlargement of the annulus.

In some embodiments, a heart valve implant 10′ can be expanded to afirst installed diameter D1 (FIG. 2A) upon initial deployment andreconfigured to a second installed diameter D2 (FIG. 2B) that is lessthan the first installed diameter D1. The reduced size of the secondinstalled diameter D2 can facilitate a reduced radial load on the nativeannulus after complete deployment of the heart valve implant 10′ at themitral valve annulus.

The embodiment illustrated in FIGS. 2A and 2B is a schematic view of theheart valve implant 10′ in expanded states. Numerical reference tocomponents is the same as previously described, except that a primesymbol (′) has been added to the reference. Where such references occur,it is to be understood that the components are the same or substantiallysimilar to previously-described components. It should be understood thatthe illustrated heart valve implant includes each of the featuresdesignated by the numbers used herein. However, as emphasized repeatedlyherein, these features need not be present in all embodiments.

With continued reference to FIGS. 2A and 2B, the frame 20′ can includeone or more connector eyelets 38. In some embodiments, the frame 20′ caninclude a plurality of eyelets 38, such as eyelets on a plurality ofstruts and/or rings of the frame. As shown, the eyelets 38 arepositioned within, or adjacent, the foreshortening portion 28′ of thedownstream end 26′ of the frame. The eyelets 38 can be configured toreceive and/or enclose a connector member 40, such as a tether, cord,fiber, or the like. In the illustrated embodiment, the plurality ofeyelets 38 protrude from the frame 20′ to provide relatively simpleaccess for the tether 40 and little resistance to movement of the tetherthrough the plurality of eyelets. As shown, the tether 40 is threadedthrough the eyelets 38 about the circumference of the frame 20′. Thefirst and second ends 42, 44 of the tether 40 extend proximally past theupstream end 22′. It will be understood that the eyelets 38 and tether40 can be positioned around any portion of the frame 20′ that isexpandable and compressible.

In some embodiments, only some of the eyelets 38 protrude outward fromthe frame 20′. More particularly, the eyelets 38 can protrude outwardwhere the tether 40 transitions from extending circumferentially aroundthe frame 20′ to extending in a longitudinal direction, such as toward adelivery device or system. In some embodiments, the eyelets 38 can lieon the same plane as the frame struts so as not to protrude radiallyinward or outward from the frame. For example, the eyelet 38 can bepositioned within the same diametral geometry as the frame. In someembodiments, the eyelets 38 are fully enclosed loops that can becircular (FIG. 2A), oval, or any other geometric shape. In someembodiments, the eyelets can have a discontinuous loop, or diameter, andthe eyelet loop can be separable or opened between two portions of theloop. In some embodiments, the eyelet is less than a full loop, e.g. ahook, or partial loop, or the like.

The number of eyelets 38 can vary based upon the characteristics of theframe, the tether, and the intended deployment of the valve implant. Forexample, a larger diameter frame can include a greater number of eyeletsto securedly affix the tether to the frame and prevent movement, orcreep, of the tether subsequent to the deployment of the valve frame.

The eyelets 38 can be formed, or fabricated, as an integral part of theframe 20′ and machined, cut, formed, stamped, or the like, out of thesame tube material as the remaining portions of the frame. In someembodiments, the eyelets 38 can be separately fabricated and coupled tothe frame 20′ by various manufacturing methods, e.g. laser welding,brazing, adhesives, or the like.

With continued reference to FIGS. 2A and 2B, the tether 40 can be anybiocompatible, flexible, suitable strength member. In some embodiments,the tether 40 can be bioabsorbable. The tether 40 can include a firstend 42 and a second end 44. The first and second ends can extendproximally out of the patients' vasculature to a valve implantdeployment device or other system that controls operation of the tether40. The tether 40 can include suitable dimensions sized to be receivedby the eyelets. The tether length can be suitably long to have the firstand second ends disposed or wrapped around the implant frame and thenone or both extend longitudinally from the frame through the vasculatureto the delivery device or other control system.

Preferably, the tether 40 and eyelets 38 are arranged so that the tetherextends about the outer diameter of the frame 20′. In some embodiments,the tether can wrap around the frame for the full circumference, or morethan a full circumference, e.g. 1¼, 1½, or the like, such that tensionapplied to the first and second ends of the tether reduces or limits thecircumference of the frame. In some embodiments, the tether can wraparound a portion of the circumference, e.g. ½, ⅔, ¾, or the like.

A method of using the tether 40 will now be described. The tether 40 canbe coupled to the compacted valve implant 10′ prior to insertion anddeployment of the same within the patient. The tether 40 can be wrappedaround the frame 20′, such as passing through eyelets 38 disposed aboutthe foreshortening portion 28′ or other portions of the frame 20′. Thefirst 42 and second 44 ends of the tether 40 can extend proximally froma pair of longitudinal transition eyelets that preferably are generallydiametrically opposed from one another on the frame. In someembodiments, the two longitudinal transition eyelets can be disposed atpositions that are other than generally 180 degrees apart from oneanother.

The valve implant 10′ can then be suitably positioned at the mitralvalve annulus and radially expanded so that the anchors 34′, 36′ graspthe annulus on both the upstream and downstream sides of the annulus.The frame can be self-expanding, e.g. fabricated with shape memorymaterial, or can be balloon expanded. The frame 20′ can expand to afirst diameter to ensure suitable engagement, or grasping, of theanchors onto, or with, the mitral valve annulus (FIG. 2A). In someembodiments, including that shown, the expanded diameter size caninfluence the engagement of the anchors 34′, 36′ because the greater thediameter, the closer the upstream and downstream anchor tips willapproach one another. This is due to the foreshortening nature of theframe as previously discussed.

Once the valve implant 10′ has been expanded to the first diameter D1,the tether 40 can be tensioned by pulling, or retracting, the first end42 and/or the second end 44 of the tether 40, such as in the proximaldirection. The tensioned tether can secure the frame to prevent furtherexpansion and/or reduce the diameter of the frame. The tension can besufficient to create an inward radial force on the frame to overcomeradial outward self-expansion force of the frame. The greater inwardradial force can reduce the diameter of the frame. The first end 42 andthe second end 44 can be pulled in tension until the diameter of theframe achieves a suitable reduced second diameter D2. The tensionedtether 40 can reduce the radial force exerted on the valve annulus andreduce the risk of an enlarged mitral valve annulus over an extendedperiod of time. Also, the diameter can preferable be dialed in to thedesired effective size for the valve implant 10′.

In some embodiments, the tether 40 can be secured in the tensionedposition to maintain the frame 20′ in the reduced diameter position. Thetether 40 can also be secured around the foreshortening portion of aself-expanding shape memory frame. Such securement can be by any methodand/or apparatus, such as knot-tying, melting, or crimping a securementstructure about the tether and/or an eyelet, and the like. In someembodiments, the tether can be bio-absorbable, as described above. Thetether may also be used in conjunction with a balloon expanded frame. Abio-absorbable tether can reduce the frame diameter to achieve elasticdeformation and can be temporarily secured to hold the frame diameteruntil the tether is absorbed into the body. In some embodiments, thetether is not required to be secured and can be removed from the bodyafter the frame diameter is reduced.

In another embodiment, the second end 44 of the tether 40 is tied orotherwise bonded to the valve frame 20′. Tether adjustment can be madeby pulling on the first end 42 of the tether 40.

In another embodiment, the tether 40 may include a plurality of one-waystop members that allow a clinician to pull and tighten the tether butprevent the tether from loosening once tightened. The one-way stopmembers can comprise a ratcheting mechanism. The one-way stop memberscan each have a sloping forward surface and a perpendicular back stopsurface. In other words, the one-way stop members can have a taperedsurface that flares out to a back wall. As the clinician pulls on thetether, the sloped or tapered surface of a member can be pulled throughthe corresponding eyelet. Once the stop member is pulled through theeyelet, the back wall or stop surface can abut the eyelet. If theclinician were to release tension on the tether, the stop surface wouldnot be able to pass back through the eyelet, and the tether thus wouldnot loosen. As such, a clinician can reduce the diameter/circumferenceof a self-expanding or other type of valve frame after deployment bypulling the tether sufficient to obtain a desired maximum circumference.The one-way stop members will then prevent loosening of the tether, andthus the tether will constrain the valve frame to that maximum desiredcircumference. The remaining portion of the tether can then be cut andremoved.

The one-way stop members can have a cross-sectional shape that istriangular, wedge shaped, bullet shaped, a half circle, arrow shaped,etc.

In still another embodiment, a ball-shaped stop is disposed at each ofthe tether first 42 and second 44 ends. The distance along the tetherbetween the first and second end stops is selected as the maximumdesired valve frame circumference. The tether 40 preferably is threadedthrough the eyelets 38 as discussed above. However the stops are sizedand shaped so that they cannot be pulled through the eyelets. When thevalve frame is compacted prior to deployment, the tether fits relativelyloose around the frame. Upon deployment the valve frame is allowed toexpand until the stops engage corresponding eyelets, defining a maximumexpansion size. Of course it is to be understood that the tether stopscould be constructed in various shapes and sizes other than theball-shaped stops described.

In some embodiments, a self-expanding valve frame is configured to havea relaxed diameter and circumference that is greater than ultimatelydesired. As such, the valve frame is biased to expand to that size.However as the frame expands, eventually the first and second stops willeach abut corresponding eyelets and thus prevent further expansionbeyond the desired diameter and circumference as defined by the tether.Since the self expanding frame is biased to expand further, it willresist other forces within the heart that would tend to compress and/orotherwise deform the valve frame.

In yet another embodiment, the tether comprises a loop that is flexible,but resists stretching. The tether preferably is threaded through theeyelets. When the valve frame is compacted prior to deployment, thetether fits relatively loose around the frame. Upon deployment the valveframe is allowed to expand until the maximum diameter of the tether loopis reached, defining a maximum expansion size.

With reference now to the illustrated embodiment of FIGS. 3A and 3B, aperspective view of another embodiment of a heart valve implant 10″ inexpanded states is shown. Numerical reference to components is the sameas previously described, except that prime symbols (″) have been addedto the reference. Where such references occur, it is to be understoodthat the components are the same or substantially similar topreviously-described components. It should be understood that theillustrated heart valve implant includes each of the features designatedby the numbers used herein. However, as emphasized repeatedly herein,these features need not be present in all embodiments.

The heart valve implant 10″ can be similar to the embodiments describedabove. The frame 20″ can comprise a self-expanding material, e.g. ashape memory material, Nitinol, or the like, or can beballoon-expandable. Preferably, an outer ring 46 is disposed about theframe 20″, such as about the foreshortening portion 28″ of the frame. Inthe illustrated embodiment, the outer ring 46 is formed separately fromthe valve frame 20″. The outer ring 46 can be configured to reduce theover-expanded, or enlarged, first diameter D1 of the frame (FIG. 3A) tothe desired reduced second diameter D2 (FIG. 3B), previously mentioned.

The outer ring 46 can take many forms. For example, the outer ring canform a pattern of undulating struts, a sinusoidal, or waveconfiguration. As illustrated, the outer ring 46 can have two rows ofundulating struts to form a series of cells of various shapes. Thus, theouter ring can be a foreshortening ring or cell, comprising a row ofconnected ovals, diamonds, circles, or similar geometric shapes. Theshapes can be coupled adjacent one another, similar to the rowsestablishing the foreshortening portion of the frame, described above.In some embodiments, the outer ring can comprise more than one row ofsimilar geometric shapes. The ovals can comprise a plurality of struts,all positioned at non-zero angles relative to the longitudinal axis,with no longitudinal struts. In some embodiments, the outer ring can bea non-foreshortening ring and can comprise longitudinal struts.

The outer ring 46 can be a self-expanding ring configured to expand orcompact the frame to the second diameter D2. In some embodiments, theouter ring 46 can be a shape memory material. In some embodiments, ashape memory outer ring 46 can expand or contract to the second diameterupon reaching body temperature, or some other set temperature. The outerring can be manufactured in a similar manner as the implant frame.

The outer ring 46 can have a relaxed expanded inner diameter that is thesame as or larger than the relaxed expanded outer diameter of theimplant frame 20″. In some embodiments, the outer ring's relaxedexpanded inner diameter can be less than the frame's relaxed expandedouter diameter, and in some such embodiments the outer ring can form aninterference fit with the frame. In further embodiments, the outer ring46 can be physically coupled to the frame 20″ by any conventionalmanufacturing method, e.g. laser welding, brazing, adhesives, fasteners,cables, or the like. The outer ring 46 can be coupled to the frame atone or more locations about the frame, such as coupling locationsgenerally equally spaced about the frame. The couplings can besufficient to prevent longitudinal migration of the outer ring about theframe. The outer ring 46 can be coupled generally in any longitudinalposition along frame, including along the foreshortening portion 28″ ofthe valve frame 20″. In some embodiments, the outer ring can bepositioned in substantially the middle longitudinal location ormid-point of the valve frame foreshortening portion.

In some embodiments, the outer ring 46 can be coupled to a power source48, e.g. an RF power source, or the like. The power source 48 can beconfigured to selectively increase the temperature of a shape memoryouter ring 46 to the set temperature. This can allow the device toexpeditiously achieve the reduced second diameter D2, rather than torely on the environment to heat the device to the desired settemperature.

In some embodiments, the power source 48 and the power source coupling50 can be removable, and can be removed from the valve implant 10″ afterthe frame 20″ has reached the desired diameter. In some embodiments, theouter ring can have no power source coupled to the ring, and the outerring may be configured to assume the second diameter at a slower ratethan the valve frame, as the temperature of the ring approaches the heattreat set temperature at a slower rate than with the assistance of thepower source.

A method of using the outer ring 46 according to an embodiment will nowbe described. The outer ring 46 can be coupled to or arranged over thevalve frame 20″ prior to insertion of the valve implant 10″ into thebody for implant deployment. The outer ring 46 can generally becompacted to a smaller diameter about the radially compacted implant10″. The outer ring 46 may be held by a retention sleeve or deliverydevice, or may be frozen in place. In some embodiments, the outer ringcan be maintained at a temperature below normal body temperature or someother set temperature to prevent premature expansion. The outer ring canbe maintained at a lower temperature by, for example, a fluidenvironment within the delivery catheter until a suitable time prior tothe final deployment sequence.

The valve 10″ can be released from the delivery device and theforeshortening portion 28″ positioned adjacent the mitral valve annulus.The valve frame 20″ can self-expand or be balloon expanded to theenlarged first diameter D1 and the anchors 34″, 36″ can engage the valveannulus on opposing sides of the annulus. The power supply 48 can thenprovide energy to increase the temperature of the outer ring 46. Forexample, RF energy can be delivered via the power source coupled to theouter ring. The increase in temperature can change the outer ring shapeas the ring recovers to the heat treated set shape memory of the reducedsecond diameter D2. The radially inward force of the outer ring 46 isgreater than the radially outward force of the frame 20″ and the framediameter correspondingly reduces to the reduced second diameter D2and/or is prevented from further radial expansion due to theradially-inward force applied by the outer ring 46. The reduced diameterpreferably does not detrimentally affect anchor engagement as theupstream to downstream anchor tip distance can be minimally increased asthe frame diameter reduces to the second diameter.

It will be understood that though the frame is generally described asmoving from a first diameter D1 to a second diameter D2, the frame mayexpand to the desired diameter without an intermediate step. The outerring, tether, or other devices can be used to limit or control theexpansion of the frame.

In another embodiment, the valve implant can have a self-expanding frameheat treated to self-expand to the second reduced diameter and yet beballoon expanded beyond the reduced second diameter to the enlargedfirst diameter. The frame upstream and downstream anchors can engage themitral valve annulus to grasp the opposing sides of the annulus in theenlarged radius configuration. The balloon can be deflated aftersuitable anchor engagement is verified, e.g. by observation methods, orthe like. The frame can then return to the heat treated reduced seconddiameter without the balloon outward radial force applied to the frameinner diameter. This can be done in many ways, including heating throughbody temperature or coupling the frame to a power source similar to thatdescribed above.

Moving now to FIGS. 4A-E, various embodiments of anchors are shown. FIG.4A schematically illustrates the anchors 34, 36 of the heart valveimplant 10 of FIG. 1. In some embodiments, the valve frame can includeone or more reverse foreshortening anchors 52, 54 as shown in FIG. 4B.This may or may not be in combination with the above describedforeshortening anchors 34, 36. The reverse foreshortening anchors 52, 54can have upstream and downstream distal tips where the longitudinalspaced distance between the two sets of tips increases when the frameradially expands, and decreases when the frame radially compacts. Thereverse foreshortening feature provides additional engaging, orgrasping, function for the anchors to remain securely engaged with themitral valve annulus when the frame diameter changes to a reduced seconddiameter.

With continued reference to FIG. 4B, the reverse foreshortening anchors52, 54 each extend from one side of the foreshortening portion 28 to theother opposing side of the foreshortening portion, but in oppositefashion. The anchor bends back on itself 180 degrees to have the anchortip point in the opposite longitudinal direction from where the anchorfirst originated. In this way, the anchor tips will move towards eachother when the foreshortening portion 28 is lengthened (FIG. 4C) and thetips will move away when the foreshortening portion 28 is foreshortened(FIG. 4E), as illustrated in FIGS. 4C-E. This is the opposite of theembodiments previously discussed. In some embodiments, one or more ofthe first and second anchors can initiate from various longitudinalpositions along the frame, e.g. non-foreshortening portion, thetransition portion, or the like.

A method of using the reverse foreshortening anchors 52, 54 will now bedescribed according to one embodiment. The reverse foreshorteninganchors 52, 54 are generally at their closest tip to tip relativelongitudinal position when the frame is in the compacted configuration.The implant 10 is delivered into the vasculature and positioned anddeployed at the mitral valve native annulus. The implant frame 20 can beexpanded to the enlarged first diameter and then reduced in diameter tothe reduced second diameter. In some embodiments, the reduction indiameter can cause the longitudinal distance between foreshorteninganchor tips to increase. In some embodiments, the reverse foreshorteninganchors can be assembled in conjunction with the normal foreshorteninganchors, but their anchor tips will move closer toward one another whenthe frame radius decreases to the reduced second diameter. In someembodiments, the reverse foreshortening anchors can be positioned atevery other circumferentially spaced expanded leg position. Thus, as thenormal foreshortening anchors decrease engagement, the secondforeshortening anchors can increase engagement by having the reverseforeshortening movement of the anchors reduce the tip to tip gap towardone anther.

Turning now to FIGS. 1 and 5-8, additional features of replacement heartvalves will be discussed. It will be understood that selected featuresfrom these embodiments can be combined with selected features of thepreviously described embodiments.

As has been mentioned, the replacement heart valve 10 of FIG. 1 is madeup of an expandable frame 20 to which a valve body 31 is attached. Thevalve body 31 can be made up of a valve skirt 33 and the plurality ofleaflets that are attached to the skirt and make up the functioningportion of the valve. The valve skirt 33 can be attached to the frame20, such as by stitches. The valve skirt 33 can be stitched, or sewn, tothe frame at numerous locations; this can include undulating struts,longitudinal struts, and apices joining struts.

With continued reference to FIG. 1, the valve skirt 33 can extend to thedownstream end 26, of the valve frame 20 and/or replacement heart valve10, when the frame is in the radially expanded state. The valve body 31advantageously prevents the leakage of blood past the native annulus andthe replacement implant heart valve when the valve body extends adjacentthe downstream end of the frame. The valve body 31 and/or the skirt 33can provide suitable contact with the native mitral valve leaflets toreduce the likelihood of blood leakage between the replacement valve andthe native leaflets. In some embodiments, the valve body 31 can beproximally spaced from the downstream end of the radially expandedframe. In some embodiments, the downstream end 35 of the valve body 31can be positioned a predetermined distance from the downstream end 26 ofthe frame, and the valve skirt can be sufficiently downstream of, oradjacent to, the native valve annulus to prevent, or to reduce thelikelihood of, bypass leakage between the replacement valve and thenative annulus.

In some embodiments, as illustrated at FIG. 5, the downstream end 35′″of the valve skirt 33′″ undulates, generally corresponding to the distalmost undulating struts of the foreshortening portion on the frame 20′″.The downstream end 35′″ of the valve skirt can be sized to match and bestitched to the undulating downstream struts of the frame 20′″. In thisembodiment, the downstream anchors 34′″ on the frame 20′″ also extend inan upstream direction from the downstream apices of the foreshorteningcells.

With reference to the illustrated embodiment of FIG. 5, numericalreference to components is the same as previously described, except thatprime symbols (′″) have been added to the reference. Where suchreferences occur, it is to be understood that the components are thesame or substantially similar to previously-described components. Itshould be understood that the illustrated heart valve implant includeseach of the features designated by the numbers used herein. However, asemphasized repeatedly herein, these features need not be present in allembodiments.

The upstream end 37′″ of the valve skirt 33′″ can also vary from theupstream end 22′″ of the frame 20′″. In particular, the valve skirt canhave varying geometry that deviates from the upstream end. The upstreamgeometry 37 of the valve skirt 33 can be tapered, as shown in FIGS. 1and 6B, or scalloped, as shown in FIGS. 5 and 6C. The furthest mostupstream portion of the tapered, or scalloped arcuate, valve skirt edgecan extend substantially to, or adjacent to, the upstream end of theframe.

Referring now to FIGS. 1 and 6B, the valve skirt 33 is constructed ofthree valve skirt pieces 80 that can be stitched together alongconnecting edges 82 and stitchingly fit against the frame inner portion.In the illustrated embodiment, the connecting edges 82 extend only aportion of the overall length of the skirt. The upstream end 37 of thevalve skirt 33 can include an upstream substantially straight edge 84that generally extends circumferentially along the inner surface of theframe and a tapered or angled edge 85. The substantially straightupstream edge 84 can extend substantially parallel to the upstream end22 of the frame 20. In some embodiments, the valve skirt can include 2,4, 5, 6 or more valve skirt pieces that can be stitched or otherwiseconnected together, or a single piece rolled and connected to itself.The skirt pieces can be shaped to fit together to correspond to theinner portion surface of the frame.

The different embodiments of valve skirt pieces shown in FIGS. 6B-C aregenerally symmetric along a longitudinal centerline of each piece. Insome embodiments, the skirt pieces are not symmetric about alongitudinal centerline, for example, if different sized upstream gapsare desired between the skirt pieces. The skirt can generally include anupstream portion, a middle portion, and a downstream portion.

The valve skirt pieces 80 of FIG. 6B have an upstream portion 37 with afirst tapered edge portion 84 on both longitudinal sides of the upstreamend. The first tapered edge 84 can extend at an angle to approximately alocation corresponding to the beginning of the transition portion of theframe. The angle of the taper can range between about 10 degrees toabout 80 degrees from the upstream end. The angle can be used in part asa factor to determine the size, or area, of the blood flow passagewaybetween the inner and outer portions of the frame upstream end.

The skirt pieces 80 can also include a second straight tapered edgeportion 88, or transition edge, shaped to accommodate the change indiameter of the frame transition portion when attached to the secondtapered edge 88 of an adjoining skirt piece 80. In some embodiments, thesecond tapered edge 88 can extend at a different angle than the firsttapered edge 86. In some embodiments, the second tapered edge 88 canhave the same angle as the first tapered edge 86. A downstream edge 90of each skirt piece is shaped to accommodate the larger diameter of theexpanded downstream frame portion when attached to the downstream edge90 of an adjoining skirt piece 80. In the illustrated embodiment, theconnecting edge 82 is made up of the stitched together transition edges88 and downstream edges 90 of adjoining skirt pieces 80.

Referring primarily to FIG. 6C, but also to FIG. 5, in anotherembodiment, each valve skirt piece 60′ can include an arcuate upstreamedge 92 forming part of a scalloped portion. The upstream edge of theskirt generally can be the center, or mid-point, of one of the pluralityof the valve skirt pieces. The three upstream arcuate edges 92 formedwith the assembled valve skirt can span the inner diameter of the frame.Preferably each arcuate edge 92 extends to a straight transition edge88, which in turn extends to a downstream edge 90. The transition edge88 and downstream edge 90 are shaped so that, when stitched together,they accommodate the frame. However, the scalloped arcuate edges 92remain unattached to one another.

In the illustrated embodiments, the stitches adjoining skirt edges ispositioned generally in line with longitudinal struts of the frame, andare stitched to the frame as shown in FIGS. 1 and 5. It is to beunderstood that differently shaped skirt pieces may be used toaccommodate differently shaped frames, such as frames without atransition portion.

In some embodiments, the angle or radius of the arcuate edge can vary,providing different sized spaced gap areas between the valve skirtpieces in the upstream portion of the frame. The spaced gap area betweenthe valve skirt pieces advantageously provides a flow path for blood topass between the inner surface and the outer surface of the upstreamportion of the valve implant. The spaced gap establishes reduced valvebody surface coverage on the frame, which reduces the frame's impact onblood flow about the implant upstream end. The upstream portion of thevalve implant is generally positioned in the left atrium after completedeployment, and the flow path areas reduce any flow impact or flowrestrictions in the left atrium attributable to the replacement valveimplant. The spaced gap also reduces the valve body mass, or volume, inthe frame upstream portion. The reduced mass, or volume, reduces thecompacted storage volume required to store the replacement heart valvein a reduced diameter tube-like body.

With reference to FIG. 6A, a valve leaflet 56 embodiment is shown. Valveskirt 33 and leaflet pieces 56 can be stitched together and implementedonto the frame to form the valve body 31. The three valve leaflets shownin FIG. 6A each include two commissural tabs 58, one tab on opposingsides of the leaflet at the downstream end of each leaflet. The tabs 58can be stitched between and to the valve skirt pieces and the valveframe such that the tabs protrude radially outwardly through the skirtlongitudinal stitch as will be described in more detail below (FIGS. 1and 5). The upstream arcuate edges of the leaflets can be stitched tothe valve skirt. For example, in FIG. 5, the upstream arcuate edges ofthe leaflets are aligned and attached to the upstream arcuate edges 92of the skirt so that the upstream edges of the skirt and the leafletsare substantially aligned about the circumference of the valve.

With reference to FIGS. 7A-B, a portion of a valve body assemblysequence is shown. The illustrated embodiment includes a portion of theimplant coupling between the valve body 31 and the frame 20. The piecesof the valve skirt 33 can be stitched together by a longitudinal stitch60 and the leaflet portions 56 can be wrapped around and stitched to theframe longitudinal strut 62. The longitudinal stitch 60 between twoadjacent valve skirt pieces can be circumferentially positioned in linewith a longitudinal strut 62 in the frame upstream portion. The upstreamend of the longitudinal stitch begins where the valve skirt proximal endtapered portions contact one another. The tapered portions and thebeginning of the longitudinal stitch 60 generally are positionedadjacent the junction between the upstream portion and the transitionportion. The pieces of the valve skirt 33 and the valve skirtlongitudinal stitch 60 can be positioned on the inner portion of thevalve frame 20, not wrapped around the longitudinal strut 62. In someembodiments, the valve skirt longitudinal stitch 60 can wrap around thelongitudinal strut 62.

The valve leaflets 56 are shown stitched to the valve skirt 33 betweenthe adjacent skirt piece ends at the skirt longitudinal stitches 60. Thecommissural tabs 58 of two adjacent leaflet pieces extend through thelongitudinal stitch 60. The two commissural tabs 58 are generallypositioned in line with the longitudinal strut 62 and adjacent theforeshortening portion of the frame 20. The longitudinal strut 62 islocated between the two radially outwardly protruding commissural tabs,as shown in FIG. 7A. The commissural tabs can be cut, or trimmed tosize, to reduce the quantity of valve leaflet material wrapped aroundthe longitudinal struts, as shown in FIG. 7B. The tabs can be wrappedaround the longitudinal strut and then stitched together and around thelongitudinal strut. In some embodiments, the commissural tabs can be theonly portion of the valve body located on the outer surface of the valveframe. In some embodiments, the commissural tabs are stitched around thelongitudinal strut and the longitudinal stitch 60 of the valve skirt islocated at a different location. This can help minimize the size of theseam.

Turning now to FIG. 8, a schematic view of another embodiment of areplacement heart valve 10″″ is shown. Numerical reference to componentsis the same as previously described, except that prime symbols (″″) havebeen added to the reference. Where such references occur, it is to beunderstood that the components are the same or substantially similar topreviously-described components. It should be understood that theillustrated heart valve implant includes each of the features designatedby the numbers used herein. However, as emphasized repeatedly herein,these features need not be present in all embodiments.

The replacement heart valve illustrates various additional features, oneor more of which may be incorporated into a respective replacement heartvalve. Similar to the other replacement heart valves discussed herein,the replacement heart valve in FIG. 8 shows a valve skirt 33″″ having ascalloped proximal end 37″″. The valve skirt 33″″ may extend all the wayto the proximal end of the valve frame or there may be a gap between theproximal end of the valve frame and the proximal end of the valve skirt.

In some embodiments, a support band 64 may be placed or positionedaround or within the valve frame 20″″ at the proximal end 22″″. Thesupport band 64 can be used to reinforce and/or constrain the valveframe at its proximal end 22″″. The support band 64 can help to controlthe expansion of the valve frame from the compacted to the expandedstate and/or limit further expansion as previously discussed. Thesupport band 64 can also be used to reduce the amount of motion thatoccurs at the proximal end 22″″ after the replacement heart valve 10″″has been implanted within the mitral heart valve or other location.

In some embodiments, the support band 64 may comprise a fabric,polyester band. The support band may comprise a no-stretch or limitedstretch material. Preferably the support band is not made of an elasticmaterial or a material known to have high elasticity.

The support band 64 can be connected to the valve frame 20″″ with aplurality of stitches, loops, knots, or other types of connections. Insome embodiments the support band 64 can sandwich the valve frame 20″″between two sides or layers of the support band. Preferably, the supportband is a single layer positioned within the valve frame and attached tothe valve frame with a plurality of stitches around one or more of thelongitudinal and/or undulating struts of the valve frame.

In some embodiments, a replacement heart valve 10″″ may include one ormore flaps or gills 66 as illustrated in FIG. 8. The flaps or gills 66can involve a cut or slit in the valve skirt material to allow foropening and closing the cut or slit. This can allow a small amount ofblood to flow through the slit 66 and around the valve skirt 33″″. Theflaps 66 can positioned anywhere on the valve skirt 33″″.

In the illustrated embodiment, a V-shaped cut 66 has been made in thevalve skirt 33″″. The flap 66 is positioned within the valve frame 20″″and as shown, can be considered as attached at the top or proximal endof the hole and hanging down into the valve. The flaps 66 can beattached at one or more sides of the hole. The flap 66 can includeadditional material so that the flap is larger than the hole made by thecut and can cover or close the entire hole. This additional material canalso prevent the flap from being forced through the hole and effectivelyblock or plug the hole.

The flaps or gills 66 in the valve skirt 33″″ can provide additionalbenefits. For example, one or more flaps 66 along the valve skirt canallow blood to flow around the valve skirt. The flaps 66 can also openand close with the flow of blood and the beating of the heart. Forexample, the flap 66 can be open during diastole and close duringsystole. The flaps 66 can reduce pressure on the valve skirt, while theprimary flow of blood still flows through the center of the replacementheart valve and through the leaflets. In some embodiments, the flap 66can be closed during diastole and open during systole. Further, in someembodiments, the flaps can be configured to allow some leakage, or aminimal amount of flow through when they are otherwise closed.

In some embodiments, the valve skirt includes the holes without theflaps. For example, the skirt can have one or more horizontal slits orslots. The slits can be positioned in the diamond or cell area of theframe, as one example. The valve skirt can also be a porous material.The valve skirt may or may not have a scalloped edge in thisconfiguration. In some embodiments without a scalloped edge, or at leastwith some region of the skirt being upstream of the leaflet upstreamedge, holes are formed only in the region of the skirt upstream of theleaflet upstream edge.

Another feature which can be included on a replacement heart valve 10″″is a layered multi-piece valve skirt 33″″. The valve skirt 33″″ can havemultiple pieces of material that overlap one another 68, 70, 72. Thiscan allow blood to flow through the valve skirt 33″″ on the sides of thereplacement heart valve 10″″ and between the layers 68, 70, 72 of valveskirt material. As shown, the proximal section of the valve skirt can bemade up of one layer of material 72. A middle section of material 70 canbe layered on top of the proximal section 72. The distal section 68 canthen be layered over the end of the middle section 70. Similar to theflaps 66, blood can flow through the layers of valve skirt fabric. Thelayers can also be loose inside of the valve frame such that they act asa valve to open and close similar to the flaps discussed above, as shownin FIGS. 9A-9B.

The multi-piece valve skirt can be made of one or more materials. Forexample, the entire skirt, one or more layer, or one or more portions ofone or more layers can be made of fabric, or of tissue, such as porcinetissue. In some embodiments, one or more layer can be a porous material,such as a porous fabric. The porous material can be configured to remainporous or to close up over time. For example, one layer such as eitherthe layer 68, or the layer 72 can be made of fabric while the other twolayers are made of tissue.

The multi-piece valve skirt can be sewn together at one or morelocations. The stitch can be a discontinuous stitch that extends aroundthe circumference and/or longitudinally. The gaps between the stitchesand the overlapping material can be configured and sized to preventprolapse. The multi-piece valve skirt can form one or more circularflaps as shown in FIGS. 9A-B. One end of the material can hang looselywithin the valve. For example, a downstream end can hang loosely insidethe valve as illustrated.

The overlapping multi-piece valve skirt, the scalloped edge, and theflaps can function as mini-leaflets to vent and/or allow flow throughthe replacement heart valve. The overlapping multi-piece valve skirt,the scalloped edge, and the flaps can also be beneficial during theimplantation process to allow flow through the replacement heart valveprior to complete implantation of the device. These features and therelated features discussed above can allow blood to flow other thandirectly through the valve. For example, a washout to the left atrium, apop-off valve, a pressure relief valve, etc. can be provided. The holes,slits, flaps, overlapping, etc. can be configured to change over time,such that more flow is allowed through initially, but overtime the flowis diminished through tissue build-up or other effects of having thereplacement valve in the body. In addition, holes, vents, slits, flaps,etc. can also be used to reduce pressure on the valve skirt when movingwhen the compressed and expanded positions.

Although this invention has been disclosed in the context of certainpreferred embodiments and examples, it will be understood by thoseskilled in the art that the present invention extends beyond thespecifically disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof. For example, the tether and eyelets of FIG. 2A and/or thereversed anchors of FIG. 4B can be used with any of the replacementheart valves of FIGS. 1, 5, and 8. In addition, while a number ofvariations of the invention have been shown and described in detail,other modifications, which are within the scope of this invention, willbe readily apparent to those of skill in the art based upon thisdisclosure. It is also contemplated that various combinations orsub-combinations of the specific features and aspects of the embodimentsmay be made and still fall within the scope of the invention.Accordingly, it should be understood that various features and aspectsof the disclosed embodiments can be combined with or substituted for oneanother in order to form varying modes of the disclosed invention. Thus,it is intended that the scope of the present invention herein disclosedshould not be limited by the particular disclosed embodiments describedabove, but should be determined only by a fair reading of the claimsthat follow.

Similarly, this method of disclosure, is not to be interpreted asreflecting an intention that any claim require more features than areexpressly recited in that claim. Rather, as the following claimsreflect, inventive aspects lie in a combination of fewer than allfeatures of any single foregoing disclosed embodiment. Thus, the claimsfollowing the Detailed Description are hereby expressly incorporatedinto this Detailed Description, with each claim standing on its own as aseparate embodiment.

What is claimed is:
 1. An intralumenal valve assembly for deployment at a diseased native valve, the intralumenal valve assembly comprising: an expandable frame comprising a proximal end, a distal end, and a longitudinal axis extending therethrough, the frame configured to radially expand and collapse for deployment at the diseased native valve, wherein the frame comprises a plurality of struts defining a plurality of cells and wherein a diameter of the proximal end is less than a diameter of a portion of the frame located distal to the proximal end, the portion of the frame located distal to the proximal end being configured to be positioned about a native valve annulus; and a valve body comprising: a valve skirt attached to the expandable frame, the valve skirt comprising a proximal end positioned near the proximal end of the frame and extending longitudinally along a length of the frame to a distal end at or near the distal end of the frame, wherein the proximal end of the valve skirt comprises edges extending at least partially distally from a proximalmost portion of the valve skirt along a length of the frame so that portions of the plurality of cells are exposed proximal to the edges, the exposed portions of the cells forming openings between struts of the frame to permit the entry of blood into the expandable frame generally transverse to the longitudinal axis, wherein the proximalmost portion of the valve skirt is spaced distally from the proximal end of the frame; and a plurality of valve leaflets attached to the skirt, wherein each of the valve leaflets extends between a fixed proximal edge and a free distal edge, the free distal edges configured to open to allow flow in a first direction from the frame proximal end to the frame distal end and configured to alternatively close to prevent flow in a second direction from the frame distal end to the frame proximal end.
 2. The intralumenal valve assembly of claim 1, wherein the proximal end of the valve skirt comprises tapered edges.
 3. The intralumenal valve assembly of claim 1, wherein the expandable frame comprises one or more rows of undulating struts at the proximal end of the frame.
 4. The intralumenal valve assembly of claim 3, wherein the edges at the proximal end of the valve skirt extend across without following the shape of at least some of the undulating struts.
 5. The intralumenal valve assembly of claim 3, wherein the edges at the proximal end of the valve skirt extend at least partially distally away from the undulating struts so that portions of the plurality of cells formed by the undulating struts are exposed proximal to the edges.
 6. The intralumenal valve assembly of claim 1, further comprising a support band at the proximal end of the expandable frame configured to limit expansion of the expandable frame, the support band positioned so as to permit the exposed portions of the cells proximal to the edges at the proximal end of the valve skirt to remain open for transverse influx of blood therethrough during use.
 7. The intralumenal valve assembly of claim 1, wherein the valve skirt further comprises a plurality of slits or gills.
 8. The intralumenal valve assembly of claim 1, wherein the frame comprises proximal anchors and distal anchors positioned on opposite sides of one or more rows of foreshortening cells, wherein expansion of the frame causes the proximal anchors and distal anchors to move toward each other.
 9. The intralumenal valve assembly of claim 1, wherein a diameter of the expandable frame at the proximalmost portion of the valve skirt is less than a diameter of the expandable frame at a distalmost portion of the valve skirt.
 10. The intralumenal valve assembly of claim 1, wherein a diameter of the expandable frame at a proximalmost end of the frame is less than a diameter of distalmost end of the frame.
 11. An intralumenal valve assembly for deployment at a diseased native valve, the intralumenal valve assembly comprising: an expandable frame comprising a proximal end, a distal end, and a longitudinal axis extending therethrough, the frame configured to radially expand and collapse for deployment at the diseased native valve, wherein the frame comprises a plurality of struts defining a plurality of cells and wherein a diameter of the proximal end is less than a diameter of a portion of the frame located distal to the proximal end, the portion of the frame located distal to the proximal end being configured to be positioned about a native valve annulus; and a valve body comprising: a valve skirt attached to the expandable frame, the valve skirt comprising a proximal end positioned at or near the proximal end of the frame and extending longitudinally along a length of the frame to a distal end at or near the distal end of the frame, wherein the proximal end of the valve skirt comprises edges extending at least partially distally from a proximalmost portion of the valve skirt along a length of the frame so that portions of the plurality of cells are exposed proximal to the edges, the exposed portions of the cells forming openings between struts of the frame to permit the entry of blood into the expandable frame generally transverse to the longitudinal axis; and a plurality of valve leaflets attached to the skirt, wherein each of the valve leaflets extends between a fixed proximal edge and a free distal edge, the free distal edges configured to open to allow flow in a first direction from the frame proximal end to the frame distal end and configured to alternatively close to prevent flow in a second direction from the frame distal end to the frame proximal end, wherein the proximal end of the valve skirt comprises scalloped, arcuate edges; wherein each of the fixed, proximal edges of the valve leaflets has an arcuate shape; and wherein each of the fixed, proximal edges of the valve leaflets is secured to one of the scalloped, arcuate edges of the valve skirt.
 12. An intralumenal valve assembly for deployment at a diseased native valve, the intralumenal valve assembly comprising: an expandable frame comprising a proximal end, a distal end, and a longitudinal axis extending therethrough, the frame configured to radially expand and collapse for deployment at the diseased native valve, wherein the frame comprises a plurality of struts defining a plurality of cells and wherein a diameter of the proximal end is less than a diameter of a portion of the frame located distal to the proximal end, the portion of the frame located distal to the proximal end being configured to be positioned about a native valve annulus; and a valve body comprising: a valve skirt attached to the expandable frame, the valve skirt comprising a proximal end positioned at or near the proximal end of the frame and extending longitudinally along a length of the frame to a distal end at or near the distal end of the frame, wherein the proximal end of the valve skirt comprises edges extending at least partially distally from a proximalmost portion of the valve skirt along a length of the frame so that portions of the plurality of cells are exposed proximal to the edges, the exposed portions of the cells forming openings between struts of the frame to permit the entry of blood into the expandable frame generally transverse to the longitudinal axis; and a plurality of valve leaflets attached to the skirt, wherein each of the valve leaflets extends between a fixed proximal edge and a free distal edge, the free distal edges configured to open to allow flow in a first direction from the frame proximal end to the frame distal end and configured to alternatively close to prevent flow in a second direction from the frame distal end to the frame proximal end, wherein the frame comprises undulating struts at its distal end, and the distal end of the valve skirt has an undulating shape corresponding to the undulating struts at the distal end of the frame.
 13. An intralumenal valve assembly for deployment at a diseased native valve, the intralumenal valve assembly comprising: an expandable frame comprising a proximal end, a distal end, and a longitudinal axis extending therethrough, the frame configured to radially expand and collapse for deployment at the diseased native valve, wherein the frame comprises a plurality of struts defining a plurality of cells and wherein a diameter of the proximal end is less than a diameter of a portion of the frame located distal to the proximal end, the portion of the frame located distal to the proximal end being configured to be positioned about a native valve annulus; and a valve body comprising: a valve skirt attached to the expandable frame, the valve skirt comprising a proximal end positioned at or near the proximal end of the frame and extending longitudinally along a length of the frame to a distal end at or near the distal end of the frame, wherein the proximal end of the valve skirt comprises edges extending at least partially distally from a proximalmost portion of the valve skirt along a length of the frame so that portions of the plurality of cells are exposed proximal to the edges, the exposed portions of the cells forming openings between struts of the frame to permit the entry of blood into the expandable frame generally transverse to the longitudinal axis; and a plurality of valve leaflets attached to the skirt, wherein each of the valve leaflets extends between a fixed proximal edge and a free distal edge, the free distal edges configured to open to allow flow in a first direction from the frame proximal end to the frame distal end and configured to alternatively close to prevent flow in a second direction from the frame distal end to the frame proximal end, wherein the valve skirt comprises three valve skirt portions connected to each other at connecting edges that extend only partially along a length of the frame.
 14. An intralumenal valve assembly for deployment at a native mitral valve, the intralumenal valve assembly comprising: an expandable frame comprising: a proximal end, a distal end, and a longitudinal axis extending therethrough, the frame configured to radially expand and collapse for deployment at the native mitral valve and wherein a diameter of the proximal end is less than a diameter of a portion of the frame located distal to the proximal end, the portion of the frame located distal to the proximal end being configured to be positioned about a native mitral valve annulus; a first set of anchors comprising ends extending proximally, the ends configured to contact the native mitral valve annulus on a left ventricular side; a valve body, wherein the valve body has a proximal end spaced distally from the proximal end of the frame; and a support band at or near the proximal end of the frame, the support band being positioned proximal to the valve body and configured to limit expansion of the expandable frame.
 15. The intralumenal valve assembly of claim 14, wherein the valve body comprises a valve skirt attached to the expandable frame and a plurality of valve leaflets attached to the valve skirt.
 16. The intralumenal valve assembly of claim 15, wherein each of the valve leaflets extends between a fixed proximal edge and a free distal edge, the free distal edges configured to open to allow flow in a first direction from the frame proximal end to the frame distal end and configured to alternatively close to prevent flow in a second direction from the frame distal end to the frame proximal end.
 17. The intralumenal valve assembly of claim 14, wherein gaps are formed between the support band and the proximal end of the valve body to permit a transverse influx of blood through the frame during use.
 18. The intralumenal valve assembly of claim 14, wherein the support band comprises a non-elastic material.
 19. The intralumenal valve assembly of claim 14, wherein the frame comprises a second set of anchors, wherein the first and second sets of anchors are positioned on opposite sides of one or more rows of foreshortening cells, wherein expansion of the frame causes the first and second sets of anchors to move toward each other. 